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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_4 | Pages 4 - 4
8 Feb 2024
Oliver WM Bell KR Carter TH White TO Clement ND Duckworth AD Molyneux SG
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This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture.

70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL).

At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups.

Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 525 - 525
1 Sep 2012
Kumar V Garg B Malhotra R
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Introduction

We compared standard NexGen Cruciate substituting-flex prosthesis with gender-specific NexGen Cruciate substituting flex prosthesis in patients undergoing bilateral total knee arthroplasty with regard to Coverage of the bone by femoral component, Clinical outcome, Radiographic outcome, Survival and complication rates, with special emphasis on patellofemoral complications.

Material & Methods

30 female patients with osteo-arthritis of the knees with similar deformity and preoperative range of motion were randomized to have one knee replaced with a gender non-specific Nexgen Cruciate substituting (Zimmer) prosthesis and the other with Gender Cruciate substituting (Zimmer) prosthesis. Follow-up clinical evaluation was done at 6, and 12 months postoperatively and then at yearly interval using “Knee Society” Recommendations. Clinical assessment of the patellofemoral joint of the replaced knees was done with the help of “Hospital for Special Surgery” patellar scoring system. The overall patient satisfaction after surgery was evaluated with use of the British Orthopaedic Association patient satisfaction score.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 479 - 479
1 Sep 2012
Nikolopoulos D Sergides N Safos G Karagiannis A Papagiannopoulos G
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BACKGROUND

As life expectancy in the population rises, osteoporotic fractures are seen most frequently in the vertebral column. Percutaneous kyphoplasty is increasingly used for pain reduction and stabilization in these patients, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain.

OBJECTIVE

To clarify whether kyphoplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures.


The Bone & Joint Journal
Vol. 105-B, Issue 11 | Pages 1196 - 1200
1 Nov 2023
Parker MJ Chatterjee R Onsa M Cawley S Gurusamy K

Aims

The aim of this study was to report the three-year follow-up for a series of 400 patients with a displaced intracapsular fracture of the hip, who were randomized to be treated with either a cemented polished tapered hemiarthroplasty or an uncemented hydroxyapatite-coated hemiarthroplasty.

Methods

The mean age of the patients was 85 years (58 to 102) and 273 (68%) were female. Follow-up was undertaken by a nurse who was blinded to the hemiarthroplasty that was used, at intervals for up to three years from surgery. The short-term follow-up of these patients at a mean of one year has previously been reported.


The Bone & Joint Journal
Vol. 102-B, Issue 3 | Pages 394 - 399
1 Mar 2020
Parker MJ Cawley S

Aims

A lack of supporting clinical studies have been published to determine the ideal length of intramedullary nail in fixation of trochanteric fractures of the hip. Nevertheless, there has been a trend to use shorter intramedullary nails for the internal fixation of trochanteric hip fractures. Our aim was to determine if the length of nail affected the outcome.

Methods

We randomized 229 patients with a trochanteric hip fracture between two implants: a ‘standard’ nail of 220 mm and a shorter nail of 175 mm, which had decreased proximal angulation (4° vs 7°) and a reduced diameter at the level of the lesser trochanter. Patients were followed up for one year by a nurse blinded to the type of implant used to determine if there were differences in mobility and pain with two nail designs. Pain was assessed on a scale of 1 (none) to 8 (severe and constant) and mobility on a scale of 1 (full mobility) to 9 (immobile).


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_14 | Pages 2 - 2
10 Oct 2023
Heinz N Bugler K Clement N Low X Duckworth A White T
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To compare the long-term outcomes of fibular nailing and plate fixation for unstable ankle fractures in a cohort of patients under the age of 65 years.

Patients from a previously conducted randomized control trial comparing fibular nailing and plate fixation were contacted at a minimum of 10 years post intervention at a single study centre. Short term data were collected prospectively and long-term data were collected retrospectively using an electronic patient record software.

Ninety-nine patients from one trauma centre were included (48 fibular nails and 51 plate fixations). Groups were matched for gender (p = 0.579), age (p = 0.811), body mass index (BMI)(p = 0.925), smoking status (p = 0.209), alcohol status (p = 0.679) and injury type (p = 0.674). Radiographically at an average of 2 years post-injury, there was no statistically significant difference between groups for development of osteoarthritis (p = 0.851). Both groups had 1 tibio-talar fusion (2% of both groups) secondary to osteoarthritis with no statistically significant difference in overall re-operation rate between groups identified (p = 0.518,). Forty-five percent (n=42) of patients had so far returned patient reported outcome measures at a minimum of 10 years (Fibular nail n=19, plate fixation n=23). No significant difference was found between groups at 10 years for the Olerud and Molander Ankle Score (p = 0.990), the Manchester-Oxford Foot Questionnaire (p = 0.288), Euroqol-5D Index (p = 0.828) and Euroqol-5D Visual Analogue Score (p = 0.769).

The current study illustrates no difference between fibular nail fixation and plate fixation at a long-term follow up of 10 years in patients under 65 years old, although the study is currently under powered.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 11 - 16
1 Jan 2020
Parker MJ Cawley S

Aims

Debate continues about whether it is better to use a cemented or uncemented hemiarthroplasty to treat a displaced intracapsular fracture of the hip. The aim of this study was to attempt to resolve this issue for contemporary prostheses.

Methods

A total of 400 patients with a displaced intracapsular fracture of the hip were randomized to receive either a cemented polished tapered stem hemiarthroplasty or an uncemented Furlong hydroxyapatite-coated hemiarthroplasty. Follow-up was conducted by a nurse blinded to the implant at set intervals for up to one year from surgery.


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This prospective randomised trial aimed to assess the superiority of internal fixation of well-reduced medial malleolar fractures (displacement □2mm) compared with non-fixation, following fibular stabilisation in patients undergoing surgical management of a closed unstable ankle fracture.

A total of 154 adult patients with a bi- or trimalleolar fracture were recruited from a single centre. Open injuries and vertically unstable medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at 12 months post-randomisation. Complications were documented over the follow-up period.

The baseline group demographics and injury characteristics were comparable. There were 144 patients reviewed at the primary outcome point (94%). The median OMAS was 80 (IQR, 60-90) in the fixation group vs. 72.5 (IQR, 55-90) in the non-fixation group (p=0.165). Complication rates were comparable, although significantly more patients (n=13, 20%) in the non-fixation group developed a radiographic non-union (p<0.001). The majority (n=8/13) were asymptomatic, with one patient requiring surgical reintervention. In the non-fixation group, a superior outcome was associated with an anatomical medial malleolar fracture reduction.

Internal fixation is not superior to non-fixation of well-reduced medial malleolar fractures when managing unstable ankle fractures. However, one in five patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the longer-term consequences of this are unknown. The results of this trial may support selective non-fixation of anatomically reduced fractures.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_1 | Pages 9 - 9
1 Jan 2019
Wickramasinghe N Maempel J Clement N Duckworth A Keating J
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Limited long term data exists comparing operatively and non-operatively treated Achilles tendon ruptures. A previous randomised controlled trial comparing early outcomes showed a short term advantage for surgery, but there are no long term prospective randomised comparisons. Our aim was to determine whether surgery conferred long term benefits in terms of patient reported outcomes or re-rupture.

64 patients (80%) were followed up with postal questionnaires. Patients were asked to complete the Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS) and EQ-5D questionnaires, and to report re-ruptures.

32 patients were treated non-operatively and 32 operatively; 59 completed the SMFA and 64 the ATRS and EQ-5D assessments. There was no significant difference in SMFA score (median 1.09, IQR 4.89 in the cast group versus 2.17 and 7.07 in the operative group; p=0.347), ATRS (median 96, IQR 18 versus 93 and 15; p=0.509), EQ-5D Index (median 1.0, IQR 0.163 versus 1.0 and 0.257; p=0.327) and EQ-5D Visual Analogue Score (median score 85, IQR 15 versus 85 and 24; p=0.650). There were 2 re-ruptures in the operative group and 4 in the non-operative group (p=0.067).

This is the first prospective, randomised, long term report comparing operative and non-operative management. At follow up between 13–17 years after injury, patients reported good function and health related quality of life. There was no significant difference in re-rupture rate between the treatment groups.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_4 | Pages 11 - 11
1 Mar 2020
Murray I Robinson P Goudie E Duckworth A Clark K Robinson C
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This prospective, randomized, controlled trial compares patient outcome after non-operative care versus open reduction and tunneled suspension device fixation (ORTSD) for grade III or IV acromioclavicular joint disruptions.

Sixty patients aged between sixteen and thirty-five years with an acute grade III or IV AC joint disruption were randomized to receive ORTSD fixation or non-operative treatment. Functional assessment was conducted at six weeks, three months, six months, and one year using the Disabilities of the Arm, Shoulder and Hands (DASH), Oxford Shoulder Scores (OSS) and Short Form (SF-12). Reduction was evaluated using radiographs. Complications were recorded, and an economic evaluation performed.

There was no significant difference in DASH or OSS at one year between non-operative and ORTSD groups (DASH score, 4.67 versus 5.63; OSS, 45.72 versus 45.63). Patients undergoing surgery had inferior DASH scores at 6 weeks (p<0.01). Five patients who failed non-operative management subsequently received surgery. Overall cost of treatment was significantly greater after ORTSD fixation (£796.22 vs £3359.73 (p<0.01)).

ORTSD fixation confers no functional benefit over non-operative treatment at one year. While patients managed non-operatively generally recover faster, a significant group remain dissatisfied following non-operative treatment requiring delayed surgical reconstruction.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_3 | Pages 11 - 11
1 Feb 2020
Johnston WD Razii N Banger MS Rowe PJ Jones BG MacLean AD Blyth MJG
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The objective of this study was to compare differences in alignment following robotic arm-assisted bi-unicompartmental knee arthroplasty (Bi-UKA) and conventional total knee arthroplasty (TKA).

This was a prospective, randomised controlled trial of 70 patients. 39 TKAs were implanted manually, as per standard protocol at our institution, and 31 Bi-UKA patients simultaneously received fixed-bearing medial and lateral UKAs, implanted using robotic arm-assistance. Preoperative and 3-month postoperative CT scans were analysed to determine hip knee ankle angle (HKAA), medial distal femoral angle (MDFA), and medial proximal tibial angle (MPTA). Analysis was repeated for 10 patients by a second rater to validate measurement reliability by calculating the intra-class correlation coefficient (ICC).

Mean change in HKAA towards neutral was 2.7° in TKA patients and 2.3° in Bi-UKA patients (P=0.6). Mean change in MDFA was 2.5° for TKA and 1.0° for Bi-UKA (P<0.01). Mean change in MPTA was 3.7° for TKA and 0.8° for Bi-UKA (P<0.01). Mean postoperative MDFA and MPTA for TKAs were 89.8° and 89.6° respectively, indicating orientation of femoral and tibial components perpendicular to the mechanical axis. Mean postoperative MDFA and MPTA for Bi-UKAs were 91.0° and 86.9° respectively, indicating a more oblique joint line orientation. Inter-rater agreement was excellent (ICC>0.99). Early functional activities, according to the new Knee Society Scoring System, favoured Bi-UKAs (P<0.05).

Robotic arm-assisted, cruciate-sparing Bi-UKA better maintains the natural anatomy of the knee in the coronal plane and may therefore preserve normal joint kinematics, compared to a mechanically aligned TKA. This has been achieved without significantly altering overall HKAA.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 480 - 480
1 Sep 2012
Andersen K Christensen A Petersen M Christensen B Pedersen N Soballe K
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Background

Randomized, controlled trials (RCTs) are generally accepted as the “gold standard” for the provision of the most unbiased measures of the efficacy of interventions but are often criticized for the lack of external validity. We assessed the external validity of a RCT examining the efficacy of local infiltration analgesia (LIA) compared with continuous epidural infusion after total knee arthroplasty (TKA)

Methods

During a one-year period, all patients consecutively admitted for elective, unilateral, primary TKA were identified as potential participants. All underwent eligibility screening to determine who were eligible for participation in a randomized controlled trial. We investigated the distribution of preoperative characteristics and postoperative variables among excluded patients, non-consenters, and enrolled and randomized participants.


Hip fractures are a major cause of morbidity and mortality, and malnutrition is a critical determinant of these outcomes. This systematic review and meta-analysis aims to determine whether oral nutritional supplementation (ONS) improves postoperative outcomes in older patients with hip fracture. An electronic systematic literature search was conducted in August 2022 using four databases. Randomized trials documenting ONS in older patients with hip fracture (aged 50+) were included. Two reviewers evaluated study eligibility, data extraction and assessed study quality. There were 812 studies identified of which 18 studies involving 1,512 patients met the inclusion criteria. The overall meta-analysis demonstrates that ONS was associated with a significant risk reduction in infective complications (odds ratio (OR) 0.54, 95%CI 0.38, 0.76), pressure ulcers (OR 0.54, 95%CI 0.33, 0.88), total complications rate (OR 0.57, 95%CI 0.42, 0.79). Length of hospital stay (LOS) was also significantly reduced (weighted mean difference (WMD) −2.01, 95%CI −3.52, −0.5), particularly in the rehabilitation LOS (WMD −4.17, 95%CI −7.08, −1.26). There was a tendency towards lower risk in mortality (OR 0.93, 95%CI 0.62, 1.4) and readmission (OR 0.52, 95%CI 0.16, 1.73), though statistical significance was not achieved. The overall compliance to ONS ranged from 64.1% to 100%, but no factors influencing compliance were identified. This systematic review was the first to quantitatively demonstrate that ONS reduces half the risk of infective complications, pressure ulcers, total complication rate and reduces LOS. ONS should be a regular and integrated part of medical practice, especially given that the compliance to ONS is acceptable


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 160 - 160
1 Sep 2012
Blakeney W Khan R Lam L Breidahl W
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Background

The long-term impact of dividing Piriformis when performing a standard posterior approach to the hip has not been assessed. A less invasive approach in which the tendon is preserved has been described (the Piriformis-sparing minimally invasive [PSMI] approach). With advances in MRI technology it is now possible to image structures in close proximity to metal without artifact. The aim of the study was to compare the MRI features (muscle grade and bulk) of the divided and repaired Piriformis tendon group (by the standard posterior approach) with the preserved tendon group (by the PSMI approach).

Methods

As part of an on-going randomized controlled trial comparing the PSMI approach with the standard posterior approach for total hip replacement, a subgroup of 20 consecutive patients who fulfilled the inclusion criteria were recruited. Patients received preoperative and 3 months and 2 year postoperative MRI scans. Patients and evaluators were blinded to allocation. Outcomes assessed included grade, volume and integrity of Piriformis.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 261 - 261
1 Sep 2012
Espandar R Mortazavi SMJ Kaseb MH Haghpanah B Yazdanian S
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Background

Medial opening-wedge high tibial osteotomy is one of the common surgical procedures in treatment of knee deformities. Many methods have been proposed to fill the medial side osseous gap. The results of using allograft as void filler compared to iliac crest autograft has not been subject to a randomized clinical trial. The purpose of this study was to examine the results of medial opening-wedge high tibial osteotomy using iliac crest allograft as compared to iliac crest autograft.

Materials & Methods

Forty-six patients with genovarum deformity were enrolled based on specific inclusion and exclusion criteria and were randomly assigned into two groups. Medial opening-wedge high tibial osteotomy was done using iliac crest allograft (23 patients) or autograft (23 patients) and the osteotomy site was internally fixed using proximal tibial T-plate. All patients were followed-up to 12 months after surgery. Anatomical indices of proximal tibia, complications of treatment, and functional outcome (using WOMAC osteoarthritis index) were assessed for both groups.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 561 - 561
1 Sep 2012
Oosthuizen B Myburgh J Tromp D Maré D Mole T Martin R Nel J
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The Versajet™ Hydrosurgery system (Smith & Nephew) offers a unique way of performing debridement using a high pressure fluid jet parallel to the surface to draw devitalized soft tissues into a cutting chamber for excision and evacuation. The aim of this study was to assess the outcome of the Versajet hydrosurgery system in the treatment of Gustilo and Anderson grade III A and III B open tibial fractures using a pilot scale prospective randomized controlled trial against conventional surgery. The primary variable was the total number of debridements until wound closure.

A total of 40 patients were recruited: 16 patients Versajet Plus™ (Smith & Nephew) hydrosurgery vs patients 24 standard surgical debridement. Baseline characteristics were well balanced with respect to the age, mechanism of injury, contamination, wound area, depth, and displacement of the bone. There was some imbalance between treatment groups where more (68.8%) Versajet patients had III A classification; vs. (37.5%) standard surgical debridement patients.

The number of debridement procedures before wound closure was for Versajet: 1 debridement procedure for 11 patients (69%), 2 for 3 patients (19%) and 3 for 2 patients (12.5%). For standard surgical patients: 1 debridement procedure for 1 patient (4.3%), 2 for 19 patients (83%) and 3 for 3 patients (13%). There was significant evidence (p<0.001) that Versajet patients required fewer debridement procedures than standard surgical debridement prior to wound closure (ratio Standard: Versajet=1.747). There was no evidence that the number of debridement procedures to achieve wound closure differed between the Gustilo and Anderson grade IIIA and grade IIIB classifications (p=0.692). The median time to wound closure was 3 days (95% CI 3 days, 5 days) for Versajet and 5 days (95% CI 4 days, 8 days) for standard surgically debrided wounds, but the difference was not statistically significant (p=0.275). There was no evidence (p=0.397) of a difference in the total number of surgical sessions (debridement or debridement with closure) required to close the wound (ratio Standard: Versajet=1.040; 95% CI (0.950, 1.137). There were no instances of post operative infection.

This pilot study has shown that on average only a single Versajet Plus hydrosurgery debridement is needed before IIIA or IIIB wounds are ready for closure and there is a trend (not significant) towards the possibility of earlier closure following the use of Versajet compared with standard surgery.


Bone & Joint Open
Vol. 2, Issue 7 | Pages 522 - 529
13 Jul 2021
Nicholson JA Clement ND Clelland AD MacDonald DJ Simpson AHRW Robinson CM

Aims

It is unclear whether acute plate fixation facilitates earlier return of normal shoulder function following a displaced mid-shaft clavicular fracture compared with nonoperative management when union occurs. The primary aim of this study was to establish whether acute plate fixation was associated with a greater return of normal shoulder function when compared with nonoperative management in patients who unite their fractures. The secondary aim was to investigate whether there were identifiable predictors associated with return of normal shoulder function in patients who achieve union with nonoperative management.

Methods

Patient data from a randomized controlled trial were used to compare acute plate fixation with nonoperative management of united fractures. Return of shoulder function was based on the age- and sex-matched Disabilities of the Arm, Shoulder and Hand (DASH) scores for the cohort. Independent predictors of an early recovery of normal shoulder function were investigated using a separate prospective series of consecutive nonoperative displaced mid-shaft clavicular fractures recruited over a two-year period (aged ≥ 16 years). Patient demographics and functional recovery were assessed over the six months post-injury using a standardized protocol.